Senior Scientist, Allogeneic T-Cell Therapy Process Development

AstraZeneca • Gaithersburg, MD

3d • $112,304 - $168,456 • Onsite

About The Position

AstraZeneca is seeking a Senior Scientist to join its Allogeneic T-Cell Therapy Process Development team in Gaithersburg, Maryland. The role supports development of clinical manufacturing processes for allogeneic CAR-T and TCR-T products, with hands-on work generating, expanding, scaling up, and characterizing human T-cell cultures. The scientist will perform gene editing and manipulate human primary cells while applying scientific judgment to optimize and characterize processes and develop scalable manufacturing approaches.

The Senior Scientist independently designs, executes, analyzes, interprets, and documents process development studies, leading work with minimal supervision and using data to determine next steps. The role involves troubleshooting technical challenges and contributing to the technical strategy for allogeneic CAR-T and TCR-T process development. The scientist collaborates with Process Development, Analytical Development, Manufacturing, Quality, Regulatory, and other partners to build process understanding, transfer technology, and support clinical manufacturing readiness. The role also provides scientific guidance and mentorship to junior scientists and associates.

Tech transfer and manufacturing-support activities include developing batch records and SOPs, real-time troubleshooting, investigating and assessing the impact of deviations, managing change controls, monitoring processes and analyzing data, and conducting risk assessments. The scientist authors or contributes to development reports, scientific publications, patents, and regulatory filings in different countries and regions. Domestic and international travel may be required, and weekend work may be required.

Requirements

• Experience culturing human primary cells; T-cell culture experience is necessary.
• Knowledge of upstream and downstream cell therapy process development, including laboratory-based development and tech transfer.
• Strong flow cytometry experience for T-cell characterization.
• Experience engineering cells in scale-up processes using manufacture-ready genome-editing tools and DNA/RNA transfection approaches.
• Familiarity with the fundamentals of design of experiments (DOE).
• Strong experimental design and data analysis skills.
• Critical and analytical thinking, with demonstrated troubleshooting and problem-solving skills based on deductive reasoning.
• Excellent teamwork and communication skills, including proven technical writing skills.
• BS in Biochemical Engineering, Biomedical Engineering, Biotechnology, or a related field and more than 6 years of relevant experience; or MS and at least 4 years of relevant experience; or PhD and at least 1 year of relevant proven experience.

Nice To Haves

• Knowledge of immunology.
• Experience with cell-editing technologies such as CRISPR/Cas9 or base editing.
• Experience with viral transduction techniques.
• GMP experience.
• Experience with cell characterization methods such as dPCR, ELISA, and NGS.
• Scientific rigor in assessing own and others’ data and a forward-looking perspective that contributes to go/no-go decisions.

Responsibilities

• Generate human CAR-T and TCR-T cells and perform in vitro expansion, scale-up, and culture-process characterization.
• Perform gene editing and manipulation of human primary cells.
• Design, execute, analyze, interpret, and document process development studies independently, leading studies with minimal supervision.
• Use data-driven decision-making to guide study next steps, troubleshoot technical challenges, and contribute to process development strategy.
• Optimize and characterize processes and develop scalable manufacturing approaches for allogeneic CAR-T and TCR-T products.
• Collaborate with Process Development, Analytical Development, Manufacturing, Quality, Regulatory, and other partner functions to support process understanding, technology transfer, and clinical manufacturing readiness.
• Provide scientific guidance and mentorship to junior scientists and associates.
• Support tech transfer through batch record and SOP development, real-time troubleshooting, deviation investigation and impact assessment, change control management, process monitoring and data analysis, and risk assessments.
• Author and contribute to development reports, scientific publications, patents, and regulatory filings.
• Travel domestically and internationally as needed.

Benefits

• Qualified retirement programs
• Paid time off, including vacation, holidays, and leaves
• Health coverage
• Dental coverage
• Vision coverage
• Eligibility for short-term incentive bonuses
• Eligibility for equity-based awards for salaried roles
• Gaithersburg campus amenities include a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria, and copy center

What This Job Offers

• Job Type: Full-time
• Career Level: Senior